Status:
RECRUITING
ConsideRAte Study - Splenic Stimulation for RA
Lead Sponsor:
Galvani Bioelectronics
Collaborating Sponsors:
NAMSA
Q2 Solutions
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
22-75 years
Phase:
NA
Brief Summary
This study will evaluate the safety, tolerability, and effects of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, ext...
Detailed Description
Participants with active rheumatoid arthritis (RA) who receive the implantable system will be randomly assigned to receive either active stimulation or sham-stimulation for 12 weeks (Period 1). Follo...
Eligibility Criteria
Inclusion
- RA of at least six months duration, per 2010 ACR/EULAR criteria
- Male or female participants, 22-75 years of age
- Active RA
- Inadequate Response to at least 2 biologic DMARDs and/or JAK-inhibitors (JAKis) including at least one TNF inhibitor
- Have an appropriate washout from previously used biological DMARDs or JAKi
- Receiving current treatment with standard dose(s) of conventional synthetic DMARD(s) or have documented history of failure due to ineffectiveness or intolerance
Exclusion
- Inability to provide informed consent
- Significant psychiatric disease or substance abuse
- History of unilateral or bilateral vagotomy
- Active or latent tuberculosis
- Known infection with human immunodeficiency virus (HIV); current acute or chronic hepatitis B or hepatitis C; previous hepatitis B
- Positive SARS COV 2 PCR screening test for COVID-19 infection (at the point of screening for this study)
- Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators)
- Previous splenectomy
Key Trial Info
Start Date :
October 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2032
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05003310
Start Date
October 19 2021
End Date
April 1 2032
Last Update
May 22 2024
Active Locations (14)
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1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
2
Medvin Research - Covina
Covina, California, United States, 91722
3
Medvin Research - Whittier
Whittier, California, United States, 90602
4
The Osteoporosis & Clinical Trials Center
Hagerstown, Maryland, United States, 21740